Medication Treatment for Opioid Use Disorder in Expectant Mothers: Conceptual Model Assessments Sub-study

Pregnancy Related Clinical Trial

— MOMs-CMA  

Official title:

NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs): a Pragmatic Randomized Trial Comparing Extended-release and Daily Buprenorphine Formulations: Conceptual Model Assessments (CMA) Sub-study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03911466
• Other study ID #: 2019-0429-2
• Secondary ID: UG1DA013732
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: July 21, 2020
• Est. completion date: January 31, 2025

Study information

• Verified date: November 2023
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a sub-study of NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs; Unique protocol ID: 2019-0429-1). Participants in MOMs will be offered the opportunity to enroll in this sub-study, which is designed to evaluate conceptual models of the mechanisms by which extended-release buprenorphine (BUP-XR), may improve mother-infant outcomes, compared to sublingual buprenorphine (BUP-SL). The additional data collected in this sub-study will be combined with data from the main MOMs trial. It is hypothesized that: (1) the buprenorphine blood levels will vary, depending on which formulation of buprenorphine was received, (2) the variation in buprenorphine blood levels will be associated with fetal behavior (including fetal heart rate variability) (3) the variation in buprenorphine blood levels will be associated with differences in mother outcomes (including medication adherence and illicit opioid use) (4) the variation in buprenorphine blood levels and in fetal behavior will be associated with infant outcomes (including neonatal opioid withdrawal syndrome and infant development).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 97
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 41 Years

Eligibility

Inclusion Criteria:

• Participating in the MOMs trial (Unique protocol ID: 2019-0429-1) Exclusion Criteria: -

Related Conditions & MeSH terms

• Drug Abuse
• Drug Abuse in Pregnancy
• Drug Addiction
• Neonatal Abstinence Syndrome
• Neonatal Opioid Withdrawal Syndrome
• Opioid-Related Disorders
• Pregnancy Related
• Substance Abuse
• Substance Withdrawal Syndrome
• Substance-Related Disorders
• Syndrome

Intervention

Drug:
• Buprenorphine Injection
Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
• Buprenorphine Sublingual Product
Sublingual buprenorphine (BUP-SL), administered daily.

Locations

Country	Name	City	State
United States	University of New Mexico Milagro Clinic	Albuquerque	New Mexico
United States	Boston Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital HOPE Clinic	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Cincinnati Health Perinatal Addictions Program	Cincinnati	Ohio
United States	Marshall Health MARC Program	Huntington	West Virginia
United States	Gateway Community Services	Jacksonville	Florida
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Pregnancy Recovery Center at Magee-Womens Hospital of UPMC	Pittsburgh	Pennsylvania
United States	CODA, Inc.	Portland	Oregon
United States	University of Utah SUPeRAD Clinic	Salt Lake City	Utah
United States	Addiction Recovery Services (ARS), Swedish Medical Center	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
T. John Winhusen, PhD	National Institute on Drug Abuse (NIDA), The Emmes Company, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmin of buprenorphine and metabolites in plasma	A blood draw at the estimated time of minimum drug concentration ("trough") to evaluate adequacy of dose for the conceptual model.	2 weeks post-randomization
Primary	Cmin of buprenorphine and metabolites in plasma	A blood draw at the estimated time of minimum drug concentration ("trough") to evaluate adequacy of dose for the conceptual model.	4 weeks post-randomization
Primary	Fetal heart rate variability	This is the measure of primary interest from the fetal evaluation (non-stress test and biophysical profile).	Estimated gestational age (EGA) approximately 36 weeks
Primary	Cmin of buprenorphine and metabolites in plasma	A blood draw at the estimated time of minimum drug concentration ("trough") to evaluate trough-to-peak fluctuation for the conceptual model.	Estimated gestational age (EGA) approximately 36 weeks
Primary	Cmax of buprenorphine and metabolites in plasma	A blood draw at the estimated time of maximum drug concentration ("peak") to evaluate trough-to-peak fluctuation for the conceptual model.	Estimated gestational age (EGA) approximately 36 weeks
Primary	Concentration of buprenorphine and metabolites in maternal plasma	A blood draw around the time of delivery to evaluate the association between drug concentration and neonatal opioid withdrawal syndrome outcomes.	Delivery
Primary	Concentration of buprenorphine and metabolites in cord plasma	Cord blood will be collected and used to estimate fetal exposure to buprenorphine.	Delivery